Technical Guidelines for Pharmaceutical Research on Oral Sustained-Release Preparations of Chemical Drugs
Request Technical Guidelines for Pharmaceutical Research on Oral Sustained-Release Preparations of Chemical Drugs
  • Local Title:化学药物口服缓释制剂药学研究技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2007-10-23
  • Implementation Date:2007-10-23
Document
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ZH Official 化学药物口服缓释制剂药学研究技术指导原则 Download
Summary

The Technical Guidelines for Pharmaceutical Research on Oral Sustained-Release Preparations of Chemical Drugs was issued on Oct.23, 2007. It gives technical guidelines for pharmaceutical research on oral sustained-release preparations of chemical drugs in China, which includes:

1. Overview

2. Basic Ideas for Research on Oral Sustained-Release Preparations

3. Commonly Used Techniques for Preparing Oral Sustained-Release Preparations

4. Basic Principles and Requirements for Release Research

5. Research on Prescription and Preparation Technology

6. Quality Research and Quality Standard Formulation

7. Stability Research

8. References